“US Supreme Court Ruling Affirms Narrow Scope of Patent Law, Encourages Competition in Pharmaceutical Research”

US Supreme Court’s Ruling on Amgen Inc. Patents Affirms Narrow Scope of Enablement

In a landmark decision, the US Supreme Court has sided with Sanofi and Regeneron Pharmaceuticals Inc. in a patent dispute with Amgen Inc. The ruling, which pertains to cholesterol drugs, has affirmed the narrow scope of a patent law requirement known as enablement. This decision allows more pharmaceutical companies to compete in the same areas of research and development, making it harder for a single company to monopolize one area of research through a broadly defined patent.

The ruling also casts a shadow on a research technique known as conservative substitution, under which Amgen laid claim to a larger pool of antibodies. Robin Feldman, a law professor at the University of California College of Law, San Francisco, said, “For the last decade, justices have been largely focused on procedural issues in patent law. With today’s unanimous decision, the court turned to core, substantive patent law.”

Implications for Patent Law and Pharmaceutical Research

The justices upheld a lower court ruling invalidating two Amgen patents covering its drug Repatha, which reduces LDL (“bad”) cholesterol levels. The decision adheres to a strict reading of US patent law and clarifies how specific a patent must be to be valid. Under the standard, patent applications must contain enough information about a claimed invention to enable someone with expertise in the field to make and use it.

The ruling has significant implications for the pharmaceutical industry, particularly for antibody patents, which cover some of drugmakers’ most valuable properties. The decision corrects a previous leniency towards broad patent claims that protected a whole category of antibodies that could perform a listed function.

Consistency Across Inventions

The court reiterated that patent law should be applied consistently across inventions, regardless of the technology involved. This means that the same enablement analysis applies to all patents, including antibody patents. The justices left room for drug companies to offer examples of what their patent covers without listing out every antibody—but only to a certain extent.

The justices also discussed how many possible antibodies Amgen’s claims could’ve covered. The discussion revealed that Amgen claimed that any sequence that has the same effect of blocking LDL receptors within this category should also be protected using what’s known as functional genus claims. This could amount to millions of possible antibody combinations, a scope that the justices found untenable.

Impact on Research and Development

The practical effects of the ruling, including whether it will encourage more research and development and lower drug prices, remain to be seen. The decision signals that rivals are theoretically free to make new discoveries in a research area that another company pioneered first, lessening the fear of being hit with an infringement lawsuit.

In the short term, practitioners are likely to file longer drug patent applications that include lengthy tables of the sequences they intend to cover. Inventors will be encouraged to draft claims focused on concrete examples, to avoid invalidation of all claims. The decision also casts doubt on the convention of relying on conservative amino acid substitutions, which are modest variations in antibody combinations, previously presumed to be covered by patent applications.

The case is Amgen Inc., et al., Petitioners vs. Sanofi, et al., U.S., No. 21-757, affirmed 5/18/23.